There have been giant leaps in medical technology over the past few years and not just in the technology being used to directly treat patients.
The methods and technologies which medical devices employ to interact or collect the information from the patient has also advanced at a considerable rate. Consider this application: A patient is residing in the comfort of their own home whilst a blood pressure monitor is being used to collect measurements continuously throughout the day. This data is sent to a hub which relays the collated information back to a remote monitoring station via a backhaul transport using technologies such as xDSL or GPRS. Here, a doctor or health professional can monitor or manage the reported data.
Most people are impressed if not amazed at this fantastic process and of course how it allows a patient to get on with life as normal. What is more fantastic is the technology which communicates with the device used by the patient and the hub. Of course it is radio technology which is being used but there are different types which are used depending on the benefits of each. One organisation which has recognised benefits of such technology is the Continua Alliance. This is an organisation which has come together to promote quality, functionality and interoperability between medical devices.
The Alliance has recognised Bluetooth, ZigBee and USB as the three main transports for communication between medical devices and uses the ISO 11073 protocol on top of the existing protocols for transporting the recorded data.
This is all interesting stuff and the advances in this technology and the ideas which are being developed are allowing people, who rely on some kind of assisted living, to lead a less interrupted life.
Although this technology is great for the patient or the doctor, however, it opens up challenges when trying to achieve regulatory compliance for a completed product. A traditional medical device would have to satisfy the requirements of the Medical Devices Directive (MDD). One route to achieve this is to test the product to the relevant harmonised standards for medical electrical equipment, namely EN/IEC 60601-1. This standard has been around for sometime, having been first published in 1977. The present edition is the third edition and has a more enlarged and substantial scope
Furthermore, because a radio has now been introduced into the product, the device must also satisfy the requirements of the Radio and Telecommunications Terminal Equipment Directive (RTTE). This Directive requires a product to comply with the “essential requirements” for Radio, EMC and Safety. There are many manufacturers who have misunderstood the requirements and have only complied with one of the directives believing they are compliant.
It is very important for manufacturers to make sure they have the correct information and guidance when performing their compliance program. One way of achieving this is to seek the services of a compliance expert who has a good level of experience in the compliance industry. More convenient would be to find a compliance expert from a professional test laboratory who can offer a complete test and approvals management service to IEC/EN 60601-1 (and the sub-parts) under one roof, so that the whole project can be completed with maximum efficiency, minimum cost and the fastest time to market. So, help is at hand and manufacturers can rest assured knowing that there are experts available to make the design and compliance process as efficient as possible.
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